MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problem Insufficient Information (3190)

Patient Problems Nausea (1970); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient¿s implant wasn¿t working right because they were still dry heaving and was nauseous every day.They stated that no one was around that knew how to fix the device.The patient was having a feeding tube put in and requested the implant to be removed at the same time.The implant was removed in (b)(6) 2019.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp).It was reported that the device was functional; the patient had severe symptoms despite the device and wanted it removed.The patient still had symptoms after the device was explanted.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9615816
• MDR Text Key: 176251240
• Report Number: 3004209178-2020-01534
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Date Device Manufactured: 12/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 81